Haemodialysis

Dialysers and Filters

Product Range
 Contents
Cardioprotective
Haemodialysis
Fresenius Polysulfone® and
Helixone® Dialysis Membranes
Dialysers and Haemofilters
FX-class Haemodiafilters
FX-class High-Flux Dialysers
FX-class Low-Flux Dialysers
Fresenius Polysulfone®
High-Flux Dialysers
and Haemodiafilters
Fresenius Polysulfone®
Low-Flux Dialysers (HPS)
Fresenius Polysulfone®
Low-Flux Dialysers
Paediatric Filters
Paediatric Filters FX paed, FX 40
Dialysis Fluid Filters
Dialysis Fluid Filter DIASAFE®plus
2
Cardioprotective
Haemodialysis
2
3
4
5
6
7
8 Despite significant improvements in the quality and
efficacy of haemodialysis therapy in recent years,
cardiovascular disease (CVD) remains the leading
9
cause of death for dialysis patients. Today, almost
every other dialysis patient dies from cardiovascular
complications.
10 Fresenius Medical Care is supporting nephrologists
worldwide in reducing their patients’ risks for cardio-
vascular morbidity and mortality.
11 Innovative membranes like Fresenius Polysulfone® or
Helixone®, modern monitoring devices like the Blood
Volume Monitor, the Blood Temperature Monitor
and Online Clearance Monitoring (OCM®), ultra-pure
dialysis fluid prepared with DIASAFE®plus and
modern ONLINE haemodiafiltration systems support
the reduction of CVD risk factors.
Moreover, one of our major goals in coming years
is the development and implementation of innovative
new therapies and products that further improve
the cardiovascular prognosis of dialysis patients.
Fresenius Polysulfone® and
Helixone® Dialysis Membranes

With over thirty years of experience in the development and manufacturing of dialysis membranes, Fresenius
Medical Care offers a broad spectrum of dialysers to meet the specific demands of the different therapy
modalities and the individual needs of every patient.

Commonly regarded as the “gold standard” for dialysis

membranes, Fresenius Polysulfone® stands for
performance and safety in haemodialysis since three
decades.
Numerous scientific publications and millions of treat-
ments reflect the good experiences and satisfaction
with this synthetic membrane among clinical staff
and patients.
The Fresenius Polysulfone® membrane is available in
the F-series low-flux and high-flux dialysers and
invests these dialysers with a high performance, a
good endotoxin retention and an excellent haemo-
compatibility.

Continuing to set the standard for novel dialysis

products, Fresenius Medical Care developed an
advanced, Fresenius Polysulfone®-based dialysis
membrane – the Helixone® membrane.
Manufacturing of the Helixone® membrane employs
a new process of membrane making – the Nano
Controlled Spinning (NCS™) Technology.
By means of this technology it is possible to create a
defined pore structure and pore distribution profile
of the inner membrane layer according to the desired
application.
Helixone® is the membrane of the FX-class of dialysers.

3
 FX-class Haemodiafilters

INLINE Steam sterilised

This series of haemodiafilters has particularly been

developed for high-volume HDF treatments with
fluid exchange rates above 15 liters per treatment.
Together with the modern housing design, the
advanced variant of the Helixone® membrane used
in these types of haemodiafilters allows for:
• An enhanced removal of low molecular-weight
substances, in particular phosphate
• An improved middle-molecule removal
• Higher fluid exchange rates during haemo-
diafiltration (> 15 L / treatment)

In vitro performance data/technical data

FX 600 FX 800 FX 1000
Ultrafiltration coeff. (mL/h x mmHg) 52 63 75
Clearance QB = 300 mL/min, QD = 500 mL/min, QF = 0 mL/min
Urea 268 276 278
Creatinine 238 250 262
Phosphate 228 238 248
Vitamin B12 165 176 178
Inulin 111 123 126
Clearance QB = 300 mL/min, QD = 500 mL/min, QF = 75 mL/min
Urea 284 289 290
Creatinine 262 271 280
Phosphate 254 262 269
Vitamin B12 199 209 211
Inulin 150 161 164
In vitro performance: T = 37°C (EN 1283, ISO 8638).
Ultrafiltration coefficients: human blood, Hct 32 %, protein content 6 %.

Effective surface (m2) 1.5 1.8 2.2

Blood flow range (mL/min) 150 – 400 200 – 500 250 – 600
Wall thickness / lumen (µm) 35/210 35/210 35/210
Priming volume (mL) 97 118 138
Membrane material Helixone®
Housing material Polypropylene
Potting compound Polyurethane
Sterilisation method INLINE Steam
Form of treatment HDF/HF
Units per box 20 20 20
Art.-No. 500 813 1 500 814 1 500 972 1

4
FX-class High-Flux Dialysers

INLINE Steam sterilised

A completely new concept of dialysers has led to

the improved performance profile of the FX-class of
dialysers achieved by various technical improve-
ments to all components of the dialyser including the
membrane Helixone®.
• Improved diffusive and convective clearances
• Refined haemodynamics
• Increased patient safety
• Simplified handling and priming
• Reduction of waste

In vitro performance data/technical data

FX 40 FX 50 FX 60 FX 80 FX 100
Ultrafiltration coeff. (mL/h x mmHg) 20 33 46 59 73
Clearance QB = 200 mL/min
Urea 170 189 193 197 –*
Creatinine 144 170 182 189 –
Phosphate 138 165 177 185 –
Vitamin B12 84 115 135 148 –
Inulin 54 76 95 112 –
Clearance QB = 300 mL/min
Urea –* 250 261 276 278
Creatinine – 210 230 250 261
Phosphate – 201 220 239 248
Vitamin B12 – 130 155 175 192
Inulin – 81 104 125 142
In vitro performance: QD = 500 mL/min, QF = 0 mL/min, T = 37 °C (EN 1283. ISO 8637). * refer to recommended blood flow range
Ultrafiltration coefficients: human blood, Hct 32 %, protein content 6 %.

Effective surface (m2) 0.6 1.0 1.4 1.8 2.2

Blood flow range (mL/min) 50 – 200 100 – 300 150 – 400 200 – 500 250 – 600
Wall thickness / lumen (µm) 35/185 35/185 35/185 35/185 35/185
Priming volume (mL) 32 53 74 95 116
Membrane material Helixone®
Housing material Polypropylene
Potting compound Polyurethane
Sterilisation method INLINE Steam
Form of treatment HD HD HD HD/HDF/HF HD/HDF/HF
Units per box 20 20 20 20 20
Art.-No. 500 884 1 500 885 1 500 886 1 500 888 1 500 890 1

5
 FX-class Low-Flux Dialysers

INLINE Steam sterilised

A modulation of the Helixone® membrane at the

nanoscale level targeting the elimination of low
molecular weight solutes led to a new generation of
low-flux dialysers with an optimal diffusive clearance.
The new low-flux Helixone® membrane offers the
following advantages:
• An increased pore size of 1.8 nm
• More even distribution of the pores
• Increased performance per unit surface area

In vitro performance data/technical data

FX 5 FX 8 FX 10
Ultrafiltration coeff. (mL/h x mmHg) 8 12 14
Clearance QB = 200 mL/min
Urea 180 191 193
Creatinine 165 178 181
Phosphate 141 160 170
Vitamin B12 88 107 121
Clearance QB = 300 mL/min
Urea 228 254 261
Creatinine 200 225 231
Phosphate 164 194 210
Vitamin B12 94 120 138
In vitro performance: QD = 500 mL/min, QF = 0 mL/min, T = 37 °C (EN 1283, ISO 8637).
Ultrafiltration coefficients: human blood, Hct 32 %, protein content 6 %.

Effective surface (m2) 1.0 1.4 1.8

Blood flow range (mL/min) 100 – 300 150 – 400 200 – 500
Wall thickness / lumen (µm) 35/185 35/185 35/185
Priming volume (mL) 54 74 95
Membrane material Helixone®
Housing material Polypropylene
Potting compound Polyurethane
Sterilisation method INLINE Steam
Form of treatment HD
Units per box 20 20 20
Art.-No. 500 483 1 500 473 1 500 474 1

6
Fresenius Polysulfone®
High-Flux Dialysers and Haemodia filters

INLINE Steam sterilised

The Fresenius Polysulfone® High-Flux Steam dialyser • High endotoxin retention capacity
range combines the advantages of a blood compatible • Unique INLINE Steam Sterilisation – no sterilisation
membrane with a safe sterilisation procedure. by-products or residues – dry
• No pretreatment rinsing procedures required
• Excellent blood compatibility
(time saving)
• Optimal performance
• Wide product range (0,7 – 2,4 m2)
• Suitable for HD, HF, HDF treatments
• Effective ␤2-microglobulin removal

In vitro performance data/technical data

F40S F50S F60S F70S HF80S HdF100S
Ultrafiltration coeff. (mL/h x mmHg) 20 30 40 50 55 60
Clearance QB = 200 mL/min
Urea 165 178 185 190 192 –*
Creatinine 140 160 172 177 180 –
Phosphate 138 158 170 174 177 –
Vitamin B12 80 100 118 127 135 –
Inulin 54 75 88 98 110 –
Clearance QB = 300 mL/min
Urea –* 225 242 245 248 271
Creatinine – 195 215 220 225 252
Phosphate – 190 210 216 220 240
Vitamin B12 – 112 134 145 155 190
Inulin – 83 97 109 120 145
In vitro performance: QD = 500 mL/min, QF = 0 mL/min, T = 37 °C (EN 1283, ISO 8637). * refer to recommended blood flow range
Ultrafiltration coefficients: human blood, Hct 32 %, protein content 6 %. Use only on machines with controlled ultrafiltration!

Effective surface (m2) 0.7 1.0 1.3 1.6 1.8 2.4

Blood flow range (mL/min) 50 – 200 100 – 300 150 – 400 200 – 500 200 – 600 250 – 600
Wall thickness / lumen (µm) 40/200 40/200 40/200 40/200 40/200 35/185
Priming volume (mL) 42 63 82 98 110 138
Membrane material Fresenius Polysulfone®
Housing material Polycarbonate
Potting compound Polyurethane
Sterilisation method INLINE Steam
Form of treatment HD HD HD/HDF HD/HDF HDF/HF HDF/HF
Units per box 12 12 12 12 12 12
Art.-No. 500 714 1 500 815 1 500 716 1 500 717 1 500 718 1 500 719 1

7
 Fresenius Polysulfone® Low-Flux Dialysers (HPS)

IINLINE Steam sterilised

High performance dialysers in the Low-Flux range • Wide product range (0.8 – 2.2 m2)
combined with the advantages of steam sterilisation. • High endotoxin retention capacity
• Unique INLINE Steam Sterilisation, no sterilisation
• Higher clearances by a new design
residues or by-products – dry
• Microundulation ensures efficient dialysate flow
• Excellent blood compatibility

In vitro performance data/technical data

F4HPS F5HPS F6HPS F7HPS F8HPS F10HPS
Ultrafiltration coeff. (mL/h x mmHg) 8 10 13 16 18 21
Clearance QB = 200 mL/min
Urea 170 179 186 188 190 –*
Creatinine 149 162 173 175 177 –
Phosphate 123 139 148 155 159 –
Vitamin B12 75 84 92 102 106 –
Clearance QB = 300 mL/min
Urea –* 227 243 247 252 259
Creatinine – 196 215 220 224 230
Phosphate – 162 175 186 193 208
Vitamin B12 – 91 100 113 118 131
In vitro performance: QD = 500 mL/min, QF = 0 mL/min, T = 37 °C (EN 1283, ISO 8637). * refer to recommended blood flow range
Ultrafiltration coefficients: human blood, Hct 32 %, protein content 6 %. Use only on machines with controlled ultrafiltration!

Effective surface (m2) 0.8 1.0 1.3 1.6 1.8 2.2

Blood flow range (mL/min) 50 – 200 100 – 300 150 – 400 200 – 500 250 – 600 300 – 600
Wall thickness / lumen (µm) 40/200 40/200 40/200 40/200 40/200 40/200
Priming volume (mL) 51 63 78 96 113 132
Membrane material Fresenius Polysulfone®
Housing material Polycarbonate
Potting compound Polyurethane
Sterilisation method INLINE Steam
Form of treatment HD
Units per box 12 12 12 12 12 12
Art.-No. 500 704 1 500 705 1 500 706 1 500 707 1 500 708 1 500 720 1

8
Fresenius Polysulfone® Low-Flux Dialysers

ETO sterilised

The wide product range is tailored to meet the • Excellent blood compatibility
requirements of the individual patient. • Wide product range (0.4 – 1.8 m2)
• High endotoxin retention capacity

In vitro performance data/technical data

F3 F4 F5 F6 F7 F8
Ultrafiltration coeff. (mL/h x mmHg) 1.7 2.8 4.0 5.5 6.4 7.5
Clearance QB = 200 mL/min
Urea 125 155 170 180 184 186
Creatinine 95 128 149 164 169 172
Phosphate 50 78 103 123 132 138
Vitamin B12 20 32 45 60 68 76
Clearance QB = 300 mL/min
Urea –* 206 222 236 240
Creatinine – 175 194 210 216
Phosphate – 115 145 155 165
Vitamin B12 – 47 62 72 82
In vitro performance: QD = 500 ml/min, QF = 0 ml/min, T = 37 °C (EN 1283. ISO 8637). * refer to recommended blood flow range
Ultrafiltration coefficients: human blood, Hct 32 %, protein content 6 %.

Effective surface (m2) 0.4 0.7 1.0 1.3 1.6 1.8

Blood flow range (mL/min) 50 – 200 50 – 200 100 – 300 150 – 400 200 – 500 250 – 600
Wall thickness / lumen (µm) 40/200 40/200 40/200 40/200 40/200 40/200
Priming volume (mL) 28 42 63 82 98 110
Membrane material Fresenius Polysulfone®
Housing material Polycarbonate
Potting compound Polyurethane
Sterilisation method ETO
Form of treatment HD
Units per box 12 12 12 12 12 12
Art.-No. 500 165 1 500 161 1 500 162 1 500 145 1 500 163 1 500 164 1

9
 Paediatric Filters FX paed, FX 40

INLINE Steam sterilisation

As members of the FX-class of dialysers, both

the FX paed and the FX 40 dialyser deliver the high
expectations on dialysers for application in paediatric
dialysis.

• State-of-the-art housing and membrane technology

• Low effective surface areas and low blood filling
volumes
• No kinking of blood lines through lateral blood
inlet ports
• Fast and easy preparation
• High-flux dialysis membrane with
high middle-molecule removal rate

In vitro performance data/technical data

FX paed FX 40
Ultrafiltration coeff. (mL/h x mmHg) 7 20
Clearance QB = 100 mL/min, QD = 300 mL/min
Urea 76 –
Creatinine 64 –
Phosphate 57 –
Vitamin B12 34 –
Inulin 20 –
Clearance QB = 200 mL/min QD = 500 mL/min
Urea – 170
Creatinine – 144
Phosphate – 138
Vitamin B12 – 84
Inulin – 54
In vitro performance: QF = 0 mL/min, T = 37 °C (EN 1283, ISO 8637).
Ultrafiltration coefficients: human blood, Hct 32 %, protein content 6 %.

Effective surface (m2) 0.2 0.6

Blood flow range (mL/min) 30 – 100 50 – 200
Wall thickness / lumen (µm) 35/220 35/185
Priming volume (mL) 18 32
Membrane material Helixone®
Housing material Polypropylene
Potting compound Polyurethane
Sterilisation method INLINE Steam
Form of treatment HD
Units per box 20 20
Art.-No. 500 822 1 500 884 1

10
Dialysis Fluid Filter DIASAFE®plus

The dialysis fluid filter DIASAFE®plus is a further

development of the successful DIASAFE® filter by
Fresenius Medical Care.
• Preparation of ultra pure dialysis fluid
(endotoxins < 0.03 IU/mL, microbial contaminations
< 0.1 CFU/mL)
• ONLINE preparation of substitution fluid for
HF and HDF treatments
• Microbiological safety through redundant double
filtration of the substitution fluid using two
DIASAFE®plus filters in series
• Checking of filter function in automatic integrity
tests
• High resistance to disinfection agents, such as
Puristeril® 340 and Diasteril®, Citrosteril®,
Sporotal® 100

Technical data
DIASAFE®plus
Membrane material Fresenius Polysulfone®
Effective surface (m2) 2.2
Housing material Polypropylene
Potting compound Polyurethane
Sealings Silicone
Filtration rate 5 mL/min mmHg (3.75 L/min bar; max. 2 bar)
Operating time Standard HD: max. 12 weeks
ONLINE HF/HDF, ONLINE priming/rinsing:
max. 12 weeks or 100 treatments
Disinfection Puristeril® 340 (peracetic acid);
Diasteril® (hydroxyacetic acid) or Citrosteril® (citric acid);
Sporotal® 100 (sodium hypochlorite) max. 11 times
Units per box 12
Art.-No. 500 820 1

Accessories Safe line™ Residual test pH Indicator test

(Puristeril® 340) (Diasteril®)
Units per box 100 100 100
Art.-No. 504 580 1 629 916 1 628 816 1

11
 © Copyright 2007 Fresenius Medical Care Deutschland GmbH
732 432 1/7 GB (2 GUT 07.07)

Fresenius Medical Care Deutschland GmbH · 61346 Bad Homburg v. d. H. · Germany · Phone: +49 (0) 6172-609-0 · Fax: +49 (0) 6172-609-2191
Head office: Else-Kröner-Straße 1 · 61352 Bad Homburg v. d. H.
www.fmc-ag.com